《再生醫療雙法》明年上路,為台灣生技產業下一個「黃金十年」揭開序幕。但全球局勢瞬息萬變,未來該如何加速應對?專家強調,除了監管和審查制度需維持彈性,必須跟上腳步、與時俱進,更重要的是讓等待奇蹟的病人,盡快在病床上用到安全有效的治療。其中細胞治療分為技術與製劑雙軌管理,雖然已有法規作為基礎,但如何加速產業化進程,讓治療選項朝向多元與標準化發展,成為法規到位後的下一個核心課題。
圖說:再生醫療雙法將上路!專家直言,未來如何加速產業化進程,成為法規到位後的下一個核心課題。(資料來源:亞家生技)
童綜合醫院細胞治療中心主任歐明哲指出,過去在特管法下,患者必須等到標準治療皆無效才能申請,「未來在再生醫療雙法的框架下,細胞治療可望於患者體能狀況較佳的早期階段介入,作為輔助或鞏固療法,有助提升整體治療成功率。」醫師解釋,完整的細胞治療流程,需先評估患者健康,接著是血液採集、體外活化與擴增,經過嚴格品質檢測,最終才將合格的細胞製劑回輸到患者體內。其中最關注的核心環節,是回輸細胞的安全性、活性與數量是否充足,因為細胞品質對治療成效的影響是決定性的關鍵。
「高品質的細胞,是經過嚴格訓練、裝備精良的特種部隊,能精準辨識並殲滅癌細胞,戰力強大且持久。相反的,品質不穩定的細胞則可能因為訓練不足,而無法有效執行任務。」歐明哲醫師強調,為了確保最高治療效果,製備與品管流程都必須嚴格遵循GTP規範的要求,而細胞製備模式創新也是一大重點。

圖說:細胞製備技術不斷創新,朝向工業4.0智能化邁進,透過軟硬體整合的「微型智能細胞製劑廠」,能有效控管、降低汙染風險,確保細胞品質穩定。(資料來源:亞家生技)
細胞製備技術已從單純自動化,進化到工業4.0的智能整合層次。亞家生技總經理吳坤烈博士分析,「關鍵在於導入AIoT(智慧物聯網)技術,與細胞製程深度融合。透過蒐集大量經驗累積的細胞培養數據,用來作為AI建模基礎,持續優化參數,生產效率將大幅提升。」而國內軟硬體整合的製造水平,足以與國際大廠分庭抗禮,像是台灣自主研發的「微型智能細胞製劑廠」,更在部署速度與客製化彈性上,具備一定優勢。
輔大生科系副教授陳雲翔則認為,「再生醫療技術不斷更迭、速度也非常快,未來法規和審查機制,必須具備足夠專業知識與彈性,才能快速回應評估像是基因編輯、異體細胞、合併療法等新興技術的出現。」尤其是台灣自主關鍵技術,必須加速產業化進程,讓細胞治療選項朝向多元與標準化發展,將是《再生醫療雙法》上路後,政府與產業界需共同關注的重要議題。
(圖文:亞家生技)

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